Treatment of molluscum

contagiosum

What is molluscum contagiosum?

• Viral infection caused by the molluscum contagiosum virus (MCV), a poxvirus

• Small umbilicated papules

• Diameter: 2-5 mm

• Skin colored or reddish, rarely whitish

• Often grouped

• Important differences to common warts (Verruca vulgaris)– Smooth and pearly/shiny surface

– Dome-shaped with a little crater in some cases

– a whitish compound (infectious) leaks from the papules under pressure

Quellen: Apothekenzeitung, Hautarzt-in-Ditzum.com

MC Verruca vul.

Occurrence of molluscum

contagiosum

Body:

• Stem, extremity, face, anogenital area

• rarely: hands and feet

• Usually less than 20 papules

• Very rarely cases with more than 100 papules

Geographic distribution :

• Worldwide from the tropics to Alaska

• Incidence is higher in warm and moist areas

Who is concerned?

Warm climate: Peak between 1-6 years of age

Cold climate: Peak between 6-10 years of age

Adults: dermatological and autoimmune disorders

Mainly affected: patients with a history of atopy (>100 papules)

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children adolecent adults

Distribution of MCV infections

Incidence/prevalence

England/Scotland:

2,4 new infections per 1 000 inhabitants and year

Germany:

• approx. 190 000 cases/ year

• 2-8% in school-aged children (Ucmak et al., 2014)

Seroprevalence (Sherwani et al. 2014)

• Germany (children and adults 0-40 years): 14.8%– Children < 1 year: 4.5%

– Children 2 – 10 years: 25% approx.150 000 cases (births 2012: 673 500)

– Population 11-40 years: 12.5%

• England: 30%

• Switzerland: 4.9%

How is MCV transmitted?

• Transmission from human to human …

– Small epithelial defects (scratches)

– Smear infection (auto- and heteroinoculation)

• Rarely through commonly used clothes or towels

– Swimming pools

– Kindergarten

• Incubation time: 2 weeks until 8 months

Spontaneous resolve?

• Spontaneous resolving process– 2-3 months (single papules)

– 6-9 months (all papules )

– 1-5 years (patients with atopic history)

• Spontaneous resolve: why should MCV be treated?→especially children experience social stigmatization and

embarrassment

→cosmetic issues

→ very high contagiousness

→ Treatment avoids spreading and transmission

Treatment should be inexpensive, simple, effective and should avoid relapse!

Invasive therapy

• Curettage

(in combination with local anesthetics)

• Forceps/ needle

• Cryotherapy

• Squeezing

• invasive

• painful

• server side effects can occur (scars)

• high risk of relapse

• time-consuming

• every single blister has to be removed

Aggressive treatment is no option !

Non-invasive treatment (keratolytic substances)

• Liquid nitrogen

• Salicylic acid

• Fluorouracil

• Imiqiumod

• Silver nitrate

• Phenol

• Chloroacetic acid

• most of these substances

act via keratolysis and

are applicable for the use

of common warts

• very corrosive

Patients need an effective, inexpensive and

simple treatment!

The solution for Molluscum contagiosum

5% potassiumhydroxid

• Simple

• Efficient

• Reliable

• medical device class 1, CE-certified for Europe

• 1ml contains 50mg potassiumhydroxid (5 % KOH)

• indicated for the topical treatment of MCV

• Recommended after two years of life

• USP: InfectoDell is the only compound for the treatment

of MC

InfectoDell may not be used:

• In areas close to eyes

• On inflammatory areas, such as inflamed papules

• On mucosa (mouth and genital area)

• For the treatment of common warts or clavus

• For immunocompromised patients

• In case of keloid

• For children younger than two years of life

!

InfectoDell mode of action

• Application 2x daily

• Keratolysis of epidermis cells (proteolysis)

• Alkaline hydrolysis of membrane lipids

(protecting cover)

• Breakdown of viral proteins

• Immune system recognizes MCV

• Inflammation is induced (after approx. 4-6 days)

• Relief after 1-5 weeks („drop off of the papules“)

Product safety

• In 2013 we improved the safety of our product to

minimize the risk of alkaline burn

• New patented container and packaging

– avoids leaking

– guarantees to remove only the needed volume for treatment

Clinical evaluation

• Proof of effectiveness – 1 Study using 2,5% KOH (Ucmak et al., 2014)

– 2 Studies using 5% KOH (Romiti et al., 2000; Jansen et al., 2007, Ucmak et al., 2014)

– 2 Studies using 10% KOH (Romiti et al., 1999; Short et al., 2006; Metkar et al., 2008)

– 1 Study using 15% KOH (Hinostroza-Da-Conceicao und Beirana-Palencia, 2004)

– 1 Study using 20% KOH (Mahajan et al., 2003)

• 80% of treated patients are free of MC after 4 weeks (Jansen et al., 2007)

• No relapse after 2-8 months

• No scars

• No severe side effects (light stinging for 1-2min after application of 5 or 10% KOH)

Advantages of InfectoDell

• Simple application

• Can be applied by parents or patient at home

• Non invasive treatment, no scars

• Does not hurt

→ high compliance

• Plenty of literature confirms effectiveness

• No relapse due to immunological reaction

• Very safe

FAQ

• Do I need to apply on each papules?

- Yes, Infectodell should be applied on each papules.

• How do antibodies attack the MC viruses?

- First Infectodell destroys the viral cells. Due to the contact with the

viral material the immune system starts producing antibodies that

detect surface on the viral envelope. Viral cells that are tagged with

the antibody, can be cleared by immune cells subsequently.

• Can MC relapse after the Infectodell treatment, ever

in human life?

- Yes, it is possible. Specific antibodies do not last a lifetime.

Mode of action

Market is difficult to define

• InfectoDell is the only compound for the

treatment of MC

• Most important “competitor”:

– curettage

• Other drugs are indicated for the treatment of

common warts

– keratolytic substances

Product performance in Germany

InfectoPharm launched the product in November 2006

Current InfectoPharm market share: approx. 40-50%

Population: 80 M

Sales 2011 - 2014

0

1.000

2.000

3.000

4.000

5.000

6.000

7.000

8.000

9.000

Nov 10

Feb 11

Jun 11

Sep 11

Dez 11

Apr 1

2Ju

l 12

Okt

12

Jan 13

Mai 13

Aug 13

Nov 13

Mrz

14

Jun 14

Sep 14

un

its

Sales are still

increasing!

2015 forecast:

80 000 pack./year

Potential:

150 000 pack./year

Literature

• Romiti et al., 2000

• Jansen et al., 2007

• Romiti et al., 1999

• Short et al., 2006

• Metkar et al., 2008

• Hinostroza-Da-Conceicao and Beirana-

Palencia, 2004

• Mahajan et al., 2003

• Ucmak et al., 2014

Features

• High complience

• Minimal side effects

• No bleeding on use

• No local anaesthetic required

• Efficiency proved by clinical trial

“Topical potassium hydroxide for the treatment of Molluscum

contagiosum saves children from the more aggressive physical

forms of treatment”

Thank you!

• Simple

• Efficient

• Reliable